Systemic SclerosisPhase 3NCT00984932
Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension
A Phase 3 study testing Rosuvastatin in people with Systemic Sclerosis, run by University of Alexandria at 1 site in Egypt.
Trial summary
Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the initial event and statins through their vasculoprotective effect might be of value in the treatment armamentarium of PAH related to SSc. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2008to Jul 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- New York Heart Association (NYHA) class III
- A mean pulmonary artery pressure (mPAP) of > 30mmHg at rest
Who cannot join
- Smoking
- Diabetes mellitus
- Hypercholesterolemia
- Hypertension
- Cardiac insufficiency
- Coexisting hepatic and renal diseases
- Use of drugs known to interact with statins.
- Patients with severe interstitial lung fibrosis
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, University of Alexandria
Alexandria, Alexandria Governorate, 203
About this study
Official title: The Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled Trial
Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the initial event and statins through their vasculoprotective effect might be of value in the treatment armamentarium of PAH related to SSc.
The aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and in the management of SSc-related PAH.
Read the detailed description
Background: Pulmonary arterial hypertension (PAH) is an acknowledged devastating complication of systemic sclerosis (SSc); difficult to manage with a poor prognosis.
Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the initial event.
Statins, through their pleotropic effects might be of value in the treatment armamentarium of PAH related to SSc.
Objectives: The aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and in the management of SSc-related PAH.
Methods: Forty SSc patients fulfilling the ACR criteria for the classification of SSc diagnosis and having PAH were recruited.
All SSc patients underwent transthoracic echocardiography and the six minute walk test (SMWT).
Patients were randomized into 2 groups; the first group (n = 23) were assigned to receive 40mg of rosuvastatin and the second group (n = 23) received placebo for 6 months.
The levels of endothelial dysfunction and inflammatory markers were assayed at baseline and after 6 months of therapy. Outcome measures assessed included exercise capacity (SMWT), MPAP, WHO functional class change, tolerability and safety.
- Conditions
- Systemic Sclerosis
- Being tested
- Rosuvastatin
- Keywords
- systemic sclerosis, pulmonary hypertension, rosuvastatin
- Medical subject headings
- Scleroderma, Systemic, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Statin, Crestor
40 mg of rosuvastatin daily
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | Not described Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity measured by the SMWT, mPAP and WHO functional class change
Measured: At baseline and After 6 months of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startSep 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Investigators
- Anna Abou-Raya, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984932
- Sponsor's protocol ID
- alexmed116613963
- Status last verified
- Sep 2009
- First submitted
- 24 Sep 2009
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00984932
- Acronym / sponsor ID
- alexmed116613963
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis, pulmonary hypertension, rosuvastatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the initial event and statins through their vasculoprotective effect might be of value in the treatment armamentarium of PAH related to SSc.
The aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and in the management of SSc-related PAH.
Detailed description
Background: Pulmonary arterial hypertension (PAH) is an acknowledged devastating complication of systemic sclerosis (SSc); difficult to manage with a poor prognosis.
Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the initial event.
Statins, through their pleotropic effects might be of value in the treatment armamentarium of PAH related to SSc.
Objectives: The aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and in the management of SSc-related PAH.
Methods: Forty SSc patients fulfilling the ACR criteria for the classification of SSc diagnosis and having PAH were recruited.
All SSc patients underwent transthoracic echocardiography and the six minute walk test (SMWT).
Patients were randomized into 2 groups; the first group (n = 23) were assigned to receive 40mg of rosuvastatin and the second group (n = 23) received placebo for 6 months.
The levels of endothelial dysfunction and inflammatory markers were assayed at baseline and after 6 months of therapy. Outcome measures assessed included exercise capacity (SMWT), MPAP, WHO functional class change, tolerability and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Rosuvastatin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- New York Heart Association (NYHA) class III
- A mean pulmonary artery pressure (mPAP) of > 30mmHg at rest
Key exclusion criteria (8 listed)
- Smoking
- Diabetes mellitus
- Hypercholesterolemia
- Hypertension
- Cardiac insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: Statin, Crestor40 mg of rosuvastatin daily | Drug | Rosuvastatin |
Primary outcome
exercise capacity measured by the SMWT, mPAP and WHO functional class change
Time frame: At baseline and After 6 months of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Abou-Raya principal investigator
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin in people with Systemic Sclerosis, run by University of Alexandria at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exercise capacity measured by the SMWT, mPAP and WHO functional class change (time frame: At baseline and After 6 months of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2009.